The sterilizer was inspected by the facility's biomed and found it to be operating properly.The cycle tape was reviewed and no issues were noted.The sterilizer was returned to service and no additional issues have been reported.Retain testing was conducted and no issues were noted with the lot number subject of the reported event.The dhr was reviewed and no issues were noted.A steris account manager discussed the reported event with hospital personnel.A staff member advised they over crushed/activated the bi after sterilization, before the incubation process.The ampoule inside should be crushed/broken, so it can release the media.The outside vial should not be cracked.When the bi is over crushed/broken, it can cause the outside and inside vial to crack leading to a potentially positive result.The steris account manager performed in-service training on the proper use and handling of the scbi.The instructions for use state: "the scbi is positive for growth if it demonstrates turbidity and/or a color change from orange to yellow.Conditions for sterilization were not achieved.Follow departmental procedures for reporting sterilization failures.".
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